Validation batches of Strangvac completed
2019-11-25
Legal Press releases
Intervacc has, together with 3P Biopharmaceuticals and LIOF-Pharma (previously Praxis Pharmaceuticals), completed the manufacturing process for Strangvac®. The validation production batches required for the forthcoming registration application to the European Medicines Agency, EMA, are thus finalized.
Submission of a registration application requires manufacturing of two batches in a scale that will be used for commercial production. The drug substance (antigens) for these batches have been produced during the summer and have been included as active components in the vaccine doses that now have been finalized. In total, 60 000 vials with vaccine doses have been manufactured and released.
“The documentation on these two commercial batches is part of the of the dossier that we will submit to the European Medicines Agency (EMA). Now that we have manufactured the vaccine on a commercial scale that meets our specifications, we have passed another very important milestone towards an approved vaccine against strangles.” says Andreas Andersson, CEO of Intervacc
Tim Wood, who has worked intensively with the project, says “We are very pleased with a robust, reliable and efficient manufacturing process.”
For more information please contact:
Andreas Andersson, CEO
E-mail: andreas.andersson@intervacc.com, Phone: +46 (0)8 120 10 601, Cell: +46 (0)73 335 99 70
or
Tim Wood, VP CMC and Regulatory
E-mail: tim.wood@intervacc.com, Phone: +46 (0)8 120 10 608
This information is information that Intervacc AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above on November 25th, 2019.
About Intervacc
Intervacc AB (publ) is a company within the Biotechnology sector. The Company´s main area is to develop modern sub-unit vaccines against economically important bacterial infections, within animal health. The company´s vaccine candidates are based on several years of research at Karolinska Institutet and Swedish University of Agricultural Research where the foundation was laid for the company´s research and development work. The Intervacc share has been listed on the NASDAQ First North Growth Market since April 2017 with Eminova Fondkommission AB, adviser@eminova.se, +46 (0)8–684 211 10 as Certified Adviser.
About 3P Biopharmaceuticals
3P Biopharmaceuticals is a leading CDMO specialized in the process development and GMP manufacturing of biologics and cell therapy products. 3P offers its customers solutions for all stages of biologics development: process as well as analytics development, preclinical and clinical material supply, commercial production. 3P is well known for its extensive experience, flexibility and team of professionals. http://www.3pbio.com/
About LIOF-Pharma
LIOF-Pharma (previously Praxis Pharmaceutical) is a European CDMO specialized in Drug Delivery, Formulation and ASEPTIC FILL FINISH, including LYOPHILIZATION of Biologics (proteins, Abs, etc.) and small molecules for clinical manufacturing and small/medium scale commercial manufacturing. Their brand new aseptic filling line can be considered as one of the best choices for small/medium size batches based on its superior process safety and flexibility, especially appropriate for high value products. http://www.grupo-praxis.com/es/
About Strangvac®
Strangvac®, a modern vaccine against Strangles, a highly contagious and serious infection in horses caused by the bacterium Streptococcus equi. Strangvac® consists of only soluble recombinant proteins, is injected intramuscularly and totally devoid of any living infectious agent. This results in a well-tolerated vaccine with excellent safety profile, as expected of a modern vaccine.
Contact information for Certified Adviser
Eminova Fondkommission AB
E-mail: adviser@eminova.se, Phone: +46 (0)8 – 684 211 10
